Table 1.
Inclusion criteria | Exclusion criteria |
---|---|
Age > 18 years | Extrahepatic disease |
Performance status (ECOG 0–2 or ASA 1–3) | MSI/dMMR |
Histological documentation of primary colorectal tumour (adenocarcinoma) | Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume) |
Local treatment performed for initial CRLM | Compromised liver function (e.g. signs of portal hypertension, INR > 1.5 without use of anticoagulants, ascites) |
New recurrence ≤ 12 months | Uncontrolled infections (> grade 2 NCI-CTC version 3.0) |
≥ 1 locally treatable CRLM (resectable* and/or ablatable) | Pregnant or breast-feeding subjects |
Total number of new CRLM ≤ 5 | Immuno- or chemotherapy ≤ 6 weeks prior to the randomization |
Chemo-naïve or history of response to CAPOX/FOLFOX/FOLRIRI | Severe allergy to contrast media not controlled with premedication |
Life expectancy of at least 12 weeks | Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results |
Adequate bone marrow, liver and renal function: Haemoglobin ≥ 5.6 mmol/L Absolute neutrophil count (ANC) ≥ 1,500/mm3 Platelet count ≥ 100*109/l Total bilirubin ≤ 1.5 times the upper limit of normal ALT and AST ≤ 2.5 × upper limit of normal (≤ 5 × upper limit of normal for subjects with liver involvement of their cancer) Albumin > 30 g/l Serum creatinine ≤ 1.5 × upper limit of normal or a MDRD ≥ 50 ml/min Prothrombin time or INR < 1.5 × ULN, unless coumarin derivates are used. Due to interactions with capecitabine, all patients using coumarin derivates will be treated with LMWH instead Activated partial thromboplastin time < 1.25 × ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician) |
|
Written informed consent |
ECOG Eastern Cooperative Oncology Group, ASA American Society of Anesthesiologists, MSI Microsatellite instability, dMMR deficient mismatch repair
*Resection for resectable lesions considered possible by obtaining negative resection margins (R0) and preserving adequate liver reserve